Overview of the CE Marking Process for the Low Voltage Directive
(also see A Primer for Garage Doors)
This overview is designed to help U.S. exporters understand the European Union Low Voltage Directive (2006/95/EC) so they can certify their products to its requirements in a timely and cost-efficient manner. The overview references key websites relating to the Low Voltage Directive (2006/95/EC), an updated list of standards for the Low Voltage Directive, and instructions on how to certify for the directive. This document also provides information on where standards can be purchased, and presents a list of labs around the country that can do CE marking testing for the Low Voltage Directive.
Please Note: The CE mark can only be applied to a product once the manufacturer can declare compliance with all applicable directives.
PHASE 1: Does the Low Voltage Directive Apply to Your Product?
The purpose of the Low Voltage Directive is to ensure the safety of people, domestic animals, and property by protecting them against hazards caused by electrical equipment. Manufacturers must ensure protection against hazards stemming from the electrical equipment by addressing factors such as temperature, arcs and radiation. Insulation must be suitable for the conditions of use. The manufacturer must also offer protection from hazards arising from external influences on the electrical equipment such as mechanical, chemical, fire, electromagnetic frequency (EMF) or thermal risks.
In effect the essential requirements of the Low Voltage Directive state that electrical equipment within the scope of the directive should not endanger persons, domestic animals or property when the equipment is properly installed, maintained and used in applications for which it was made.
All electrical equipment designed for use with a voltage rating between 50 and 1000 volts for alternating current (AC) or between 75 and 1500 volts for direct current (DC) are covered by the Low Voltage Directive. Voltage ratings refer to the voltage of the electrical input or output, not to voltages which may appear inside the equipment.
Generally speaking, products that must comply with the Low Voltage Directive are electrical consumer products or capital goods that are designed to operate within these voltage limits. Examples are:
Battery-operated equipment outside the voltage rating is naturally outside the scope of the Low Voltage Directive. However, accompanying battery-chargers, as well as equipment with integrated power supply units within the voltage ranges of the Directive, are within the scope of the LVD. This applies also to battery-operated equipment with a supply voltage rating under 50 V AC and 75 V DC, with accompanying mains power supply units (e.g. notebooks). So when the notebook and power supply unit are distributed together, they both need to meet the CE mark requirements for the Low Voltage Directive, even if the notebook has a battery-powered voltage under the range of the LVD. (The notebook would also have to meet the CE mark requirements for the EMC Directive).
Additionally, the Low Voltage Directive applies to products for which the European Commission has mandated a Low Voltage Harmonized Standard. For the list of Low Voltage Harmonized Standards, please consult the New Approach Standardisation in the Internal Market and click on “Directives and Standards.” Then, click on the box entitled “References Harmonized Standards” in the column marked Low Voltage Equipment.
Annex II of the Low Voltage Directive lists the following equipment as being outside the scope of directive:
The products listed in Annex II above are excluded from the Low Voltage Directive because they are regulated under national laws, international agreements, or other New Approach Directives.
For information on which components need to be certified for the Low Voltage Directive, please refer to the NIST booklet entitled, “A Guide to the EU Low Voltage Directive” . It is generally accepted that components such as transformers and electrical motors should be CE-marked. Components such as those should also undergo a further assessment of the safety aspects related to their incorporation into the final product. Other components such as integrated circuits, transistors, diodes, triacs, and passive components such as capacitors, inductors, resistors and filters do not fall within the scope of the Low Voltage Directive and do not need to be CE-Marked.
PHASE 2: CE Marking Requirements for the Low Voltage Directive
The essential requirements of the Low Voltage Directive are contained in Annex I of the Directive. The essential requirements describe the safety objectives of the directive in terms of general conditions, protection against hazards arising from electrical equipment, and protection against hazards that may be caused by external influences on the electrical equipment. Compliance with these requirements is mandatory.
A manufacturer can self-certify to the requirements of the Low Voltage Directive by conforming to the European standards that apply to its product. The manufacturer must get a test result either in house or from a lab, in order to prove product conformance to the appropriate European harmonized low voltage standard(s). Manufacturers can use either an independent lab or a third party lab affiliated with an EU notified body. The list of these standards can be found on the European Commission’s website by clicking on “Directives and Standards” and then clicking on “References Harmonized Standards” across from the Low Voltage Directive. Compliance with the harmonized standards gives assurance to the manufacturer that the product tested meets the essential requirements of this directive.
A manufacturer is not required to use European standards to comply with the Low Voltage Directive. If the manufacturer does not use European standards, then the company will have to indicate in its technical file what solutions it used to meet the requirements of the directive.
PHASE 3: Identify the European Standards for the Low Voltage Directive that Apply to Your Product
The Low Voltage Directive sets down rules for the use of standards for gaining CE marking approval. Article 5 states that application of European “harmonized” standards (developed by a European standards-setting body and recognized by the Commission and Member States as EU wide standards) will give the presumption of conformity for CE marking requirements for the Low Voltage Directive. If there are no harmonized standards for the manufacturer’s product, then Member States should recognize international standards, such as those developed by the International Electrotechnical Commission (IEC). In the absence of harmonized European or international standards, Member State authorities should accept national standards in effect in the Member State of manufacture; or from the U.S. exporter’s point of view, Member State authorities should recognize national standards used by a U.S. company in the Member State receiving the product.
Manufacturers are not required to use harmonized European standards, but if they do not, then they bear the burden of proof that they have met the requirements of the directive. Article 8 cautions the manufacturer: “In the event of a challenge, the manufacturer or importer may submit a report, drawn up by a body, which is notified…” In other words, in the event of a challenge, a manufacturer using standards which do not carry a presumption of conformity might be well advised to enlist the aid of a notified body or one of the notified body’s U.S. branches.
If a company chooses to use the European harmonized standards, its technical staff should go through the list of standards and identify the standards that apply to its product, and order those standards from a designated outlet, some of which are listed in the Consultants/Ordering Standards.
In general, the standards for the Low Voltage Directive can be divided into seven major categories: safety of households and similar electrical appliances; safety of machinery; safety of handheld electrical tools; safety of information technology equipment; safety of household electronic appliances; luminaries (lighting); and safety requirements for electrical equipment for measurement, control, and laboratory use.
PHASE 4: Conform to the Appropriate Standards
Once the company has ordered and received the appropriate European standards (possibly from the list under the Consultants/Ordering Standards), its engineering or technical department can apply the standards to the design and production phase of its product. The standards contain all the detailed information, diagrams, and tests necessary to meet the requirements of the Low Voltage Directive. The directive is general in scope, stating that people, property, and animals must be protected from:
The detailed information (and diagrams) of what is actually required to meet the requirements of the Low Voltage Directive is found in the European standards.
PHASE 5: Get a Lab Test to Prove Conformance to the Low Voltage Standards
Once a company has chosen the standards for the Low Voltage Directive, it will need a lab result to prove that the standards have been met. For a list of labs that can do testing and certification for the Low Voltage Directive, see the Testing/Certifying Labs. This list is not an endorsement for any particular laboratory. There are other labs, not listed on our link that can do testing for the Low Voltage Directive.
If you have used European standards, you can self-certify for the Low Voltage Directive. Indicate to the lab that you only need a test result verifying the European standards you have used. The lab charges more for assessing the product, applying the standards, and producing a test result than it will for producing only a test result showing conformance to the European standards. As long as the manufacturer has conformed to European standards, it can get a test result from any lab that has the equipment to test to the standard. The manufacturer can go to an EU-affiliate lab or to an independent lab. In fact, if the company has the equipment to test to European standards, it can do the testing in-house.
After a product has successfully passed the tests, the manufacturer needs to obtain a certificate from the lab showing the product has met standards for the Low Voltage Directive. Together with the Quality Control system, this certificate will form the core of the company’s technical file (see PHASE 7).
PHASE 6: Set up a Quality Control System
The manufacturer is obligated to set up a quality control system to ensure that products it produces in the future will also meet CE mark requirements for the Low Voltage Directive, the same as the manufacturer’s original CE-marked product documented in the technical construction file. The manufacturer can design its own quality control system. This system does not have to be ISO 9000, though ISO 9000 is widely recognized and could be advantageous for marketing purposes.
In addition to ensuring that products manufactured are similar to the type tested sample, compliance with LVD standards exists requiring production units to be subjected to routine production line tests such as Electric Strength (Hipot) and Protective Earth Resistance tests to ensure that all units manufactured have an adequate insulation system and a reliable protective earth connection. Results and details of the tests should be logged against the product serial number and retained as a Quality Record.
PHASE 7: Assemble a Technical File
The manufacturer is required to compile a technical file that must contain the following:
The manufacturer or its authorized representative must keep a copy of the declaration of conformity (see PHASE 9) with the technical documentation. Also, the manufacturer should refer to the details of its quality control system in the technical file. The significance of the quality control system is described in PHASE 6.
Annex IV of the Low Voltage Directive states that the manufacturer or his authorized representative established within the Community must keep a copy of the technical file on Community territory at the disposal of the relevant national authorities for inspection purposes for a period of at least 10 years after the last product has been manufactured.
Where neither the manufacturer nor his authorized representative is established within the Community, this obligation is the responsibility of the person who places the electrical equipment on the Community market.
PHASE 8: Affix the CE Marking to Your Product
Annex III of the Low Voltage Directive has a picture of the CE mark. To view this picture, go to the website New Approach Standardisation in the Internal Market, click on “Directives and Standards” and then click on 2006/95/EC under Low Voltage Equipment. Then, click on the pdf section of the square marked EN for English. The CE mark must be indelibly affixed to a product. It does not have to be branded onto a product but it must be affixed so that it will not come off. The two letters (CE) must have the same vertical dimension, which may not be less than 5 millimeters in height. If your product is covered by more than one CE marking directive (such as by the Machine, Electromagnetic Compatibility, and Low Voltage Directives), then it is assumed that the CE marking will not be put on the product until CE marking requirements have been met for all the directives the manufacturer’s product falls under. Annex III also states that if the CE marking is reduced or enlarged, the proportions given in the drawing in Annex III must be respected.
PHASE 9: Declaration of Conformity
The declaration of conformity is the document showing that the manufacturer, or his authorized representative, has met the requirements of all applicable CE marking directives for the product being placed on the EU market. The declaration of conformity could accompany each shipment to show EU customs authorities that the imported product meets CE mark requirements. The declaration of conformity then goes to the customer who keeps it on file in case EU authorities have questions about the compliance and origin of the product. A company official from the U.S. manufacturer must sign the declaration of conformity to show that the firm is backing its claim of meeting CE marking requirements.
For a sample declaration of conformity, go to the Declaration of Conformity Example. There is no mandatory format for the declaration of conformity; however, general guidance is given in Draft Certif 2005 -2 from European Commission references EN 45014:1989 “General criteria for suppliers’ declaration of conformity.”
However, the declaration of conformity must include the following pieces of information according to Annex III of the Low Voltage Directive:
Phase 10: Keep Posted on Updates of Standards Which Might Affect Your Product
The European Union issues new low voltage standards periodically. U.S. companies complying with the CE marking for the Low Voltage Directive should check the European Commission’s website once every 4-6 months to see if new standards have been issued that might apply to their product. These new standards usually have a lead time of a couple of years, giving companies time to conform to the new requirements, which usually contain requirements and/or information additional to that in the standards they replaced. Once the new standard is published in the Official Journal, it is usually accompanied by a “Date of cessation of presumption of conformity of the superseded standard “DOCOPOCOSS, after which the old standard no longer gives presumption of meeting CE marking requirements. A company that has not stayed current and fails to comply with a new standard is technically in violation of the CE marking requirements and could be prosecuted by EU authorities.
More Information is Available:
If you need more information on getting the CE marking for the Low Voltage Directive, call either of the Department of Commerce EU specialists: Bob Straetz at 202-482-4496 in the Office of the European Union (OEU) or Sylvia Mohr at 011-32-2-508-2675 at the U.S. Mission to the EU, Brussels, Belgium.
Duquesne University Center for International Regulatory Assistance partially funded by the U.S. Small Business Administration and the Market Development Cooperator Program of the U.S. Department of Commerce, has information on CE marking.